A Study of SKB571 Combination Therapy in Participants With Non-Small Cell Lung Cancer (NSCLC)

This is a multicenter, open-label, Phase II clinical study to evaluate the efficacy, safety, tolerability, PK characteristics, and immunogenicity of SKB571Combination Therapy in participants with Non-Small Cell Lung Cancer (NSCLC). Approximately 150 subjects will be enrolled in this study, including 3 cohorts.

Inclusion criteria

• Male or female, age ≥ 18 years and ≤ 75 years at the time of signing the informed consent form (ICF).
• Participants must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC).
• At least one measurable lesion as assessed by the investigator according to RECIST v1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy ≥ 12 weeks as assessed by the investigator.
• Adequate organ and bone marrow function.
• Male and female participants must agree to use highly effective methods of contraception during the study treatment period.
• Participants must voluntarily join this study, sign the ICF, and be able to comply with the visits and related procedures specified in the protocol.

Exclusion criteria

• Participants with other malignant tumors within 3 years before the first dose of study treatment.
• Active or untreated central nervous system (CNS) metastasis.
• Current uncontrolled concomitant diseases
• Clinically severe lung damage due to complications of lung disorder
• Participants with a history of interstitial lung disease (ILD)/non-infectious pneumonitis
• A history of severe skin diseases
• Unresolved toxicity from prior anti-tumor therapy
• Serious infection within 4 weeks before the first dose of study treatment
• Known active pulmonary tuberculosis.
• Participants who have undergone major surgery or had severe trauma within 4 weeks before the first dose, or are expected to require major surgery during the study.
• Known history of allogeneic organ transplant or allogeneic hematopoietic stem cell transplant.
• Pregnant or breastfeeding women.
• Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.